Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects

Coronary Artery Disease Clinical Trial

Official title:

Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects: A Pilot Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02422446
• Other study ID #: 2013D003968
• Status: Terminated
• Phase: Phase 3
• Start date: April 2015
• Est. completion date: March 1, 2017

Study information

• Verified date: February 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot trial seeks to obtain preliminary data on the effects of eicosapentaenoic acid (EPA) (4g/d) on endothelial function measured via endopat2000 after 12 weeks of intervention among adults with elevated triglycerides and type 2 diabetes.

Description:

Thirty adults aged 30-75 y will be randomized to either 4 g/d of eicosapentaenoic acid or no drug for 12 weeks. Endothelial function will be measured at baseline and after 12 weeks. in a secondary aims, we will evaluate effects of eicosapentaenoic acid (EPA) on plasma levels of c-reactive protein, oxidized low-density lipoprotein cholesterol, and endothelin-1.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 1, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 30+ years

• Hypertriglyceridemia (150-400 mg/dl)

• Statin use for at least six months at the time of screening

• Type 2 diabetes treated with diet and/or oral hypoglycemic agents diagnosed 1+ year

• Ability to provide informed consent and provide blood samples

• Willingness to abstain from fish oil, EPA, over the counter niacin, and other omega-3 fatty acid supplements during the study period (12 weeks)

• Ability to travel to the study site at Brigham and Women's Hospital for 3 study visits

• Reactive hyperemia index (RHI) of = 2.0

Exclusion Criteria:

• Eating disorder or heavy drinkers

• Treatment with chronic prescription pharmacotherapy for metabolic or cardiovascular disease management or risk factor modification

• Pregnant or lactating women

• Statin use <6 months at the time of screening

• Allergy to EPA, fish oil, or other omega-3 fatty acids

• Current use of insulin, cyclophosphamide, estrogen, fibrates, niacin, hormone replacement therapy, testosterone, oral contraceptives, growth hormones, insulin-like growth factor-1, and other systemic steroids.

• Inability to provide informed consent or blood samples

• History or prevalent diagnosis of cancer, asthma, kidney insufficiency, stroke, seizures, allergic disorders, or congestive heart failure

• Diagnosis of diabetes < 1 year prior to enrollment

• Intention to move out of greater Boston area within one year

• Current use of omega-3 supplements, fish oil, or >2 servings of fish per week

• Bleeding disorder or uncontrolled endocrine (i.e., thyroid) or metabolic disorders

• Treatment with blood thinning drugs (i.e. warfarin and clopidogrel)

• Major surgical operation 3 months before or after screening

• Organ transplantation

• Current participation in another trial or plan to do so during the study

• Inability to give informed consent or to travel to the study center at Brigham and Women's Hospital

• RHI of >2.0

• Triglycerides <150 mg/dl or >400 mg/dl

• Body mass index of 40+ kg/m2

Related Conditions & MeSH terms

• Coronary Artery Disease
• Type 2 Diabetes

Intervention

Drug:
• Icosapent ethyl
icosapent ethyl is eicosapentaenoic acid, an omega-3 fatty acid that naturally occurs in fish

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Endothelial Function at 12 Weeks Using Reactive Hyperemia Index (RHI)	Digital pulse amplitude will be measured with a fingertip peripheral arterial tonometry (PAT) device (Endo-PAT2000, Itamar Medical) in a supine position. Baseline pulse amplitude will be measured for 5 minutes, then the arterial flow will then be interrupted for 5 minutes with a cuff placed on a proximal forearm. Pulse amplitude will be recorded electronically and analyzed by a computerized and automated algorithm. The change from the baseline measurement will be expressed as the reactive hyperemia index (RHI). We will calculate the pulse amplitude response to hyperemia for each 30-second interval as a ratio of the post-deflation pulse amplitude to the baseline pulse amplitude as described previously. The RHI ratio will be computed by dividing the ratio obtained on the test side over the ratio from the control finger. We will assess change in RHI ratio between baseline value and 12-week value after the intervention.	Between baseline and 12 weeks
Secondary	Change in Endothelin-1 (ET-1), High-sensitive C-reactive Protein (hsCRP), and Oxidized LDL Between Baseline and 12 Weeks	Plasma hsCRP will be measured by Sandwich enzyme linked immunosorbent assay (ELISA). Plasma oxidized LDL and plasma ET-1 will be measured using a commercially available sandwich-enzyme immunoassay kit (R & D).	change between baseline and 12 weeks post-intervention